Obstructive Hypertrophic Cardiomyopathy (oHCM)LVMI and oHCMNCT06609382
Left Ventricular Mass Index Predicts Clinical Outcomes in Patients with Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy
An observational study of Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Changrong Nie at 1 site in China.
Trial summary
In this study, we aimed to analyze the association between left ventricular mass index and clinical outcomes to provide the potential indicator for worse survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy (oHCM)
- What is being tested?
- Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes)
- How many people
- 490 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2011to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: oHCM who underwent septal myectomy and had at least one CMR image before surgery.
Who may be able to join
None listed.
Who cannot join
- (1) Combined right ventricular outflow tract obstruction requiring right ventricular outflow tract dissection. (2) Combined mitral or aortic valve organic lesions requiring valve replacement surgery. (3) Apical ventricular aneurysm formation requiring ventriculotomy. (4) Previous septal reduction therapy, including alcohol ablation or septal myectomy. (5) patients did not undergo cardiac magnetic resonance examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Left Ventricular Mass Index in Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy
In this study, we aimed to analyze the association between left ventricular mass index and clinical outcomes to provide the potential indicator for worse survival.
Read the detailed description
This retrospective study aimed to determine the prognostic value of left ventricular mass index in predicting clinical outcomes, including all-cause death, new-onset or recurrent atrial fibrillation, and a composite endpoint of all-cause death, heart failure,permanent pacemaker implantation, new-onset or recurrent atrial fibrillation, and stroke.
- Being tested
- Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes)
- Keywords
- left ventricular mass index, all-cause death, survival, obstructive hypertrophic cardiomyopathy, septal myectomy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes)Other
Patients were grouped by the cutoff value of left ventricular mass index (LVMI) for all cause death, and the Maximally Selected Rank Statistics method was used to determine the optimal cutoff point of LVMI for death.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive hypertrophic cardiomyopathy who underwent septal myectomy | Patients who had at least one cardiac magnetic resonance examination before surgery. Receives: Other: Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Any death observed one month after discharge.
Measured: One month after discharge
Secondary outcomes (1)
composite endpoint
Composite endpoint included all-cause death, and nonfatal adverse events, with nonfatal adverse events defined as rehospitalization for heart failure, permanent pacemaker implantation, new-onset or recurrent atrial fibrillation, and stroke.
Measured: One month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start1 Jun 2011
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changrong Nie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Changrong Nie, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609382
- Sponsor's protocol ID
- 2020-1315
- Other IDs
- 2022-GSP-GG-29
- Acronym
- LVMI and oHCM
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Left Ventricular Mass Index in Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy
- ClinicalTrials.gov ID
- NCT06609382
- Acronym / sponsor ID
- LVMI and oHCM / 2020-1315
- Keywords
- left ventricular mass index, all-cause death, survival, obstructive hypertrophic cardiomyopathy, septal myectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Changrong NieUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we aimed to analyze the association between left ventricular mass index and clinical outcomes to provide the potential indicator for worse survival.
Detailed description
This retrospective study aimed to determine the prognostic value of left ventricular mass index in predicting clinical outcomes, including all-cause death, new-onset or recurrent atrial fibrillation, and a composite endpoint of all-cause death, heart failure,permanent pacemaker implantation, new-onset or recurrent atrial fibrillation, and stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive hypertrophic cardiomyopathy who underwent septal myectomy | – | Other: Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes)Patients who had at least one cardiac magnetic resonance examination before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- oHCM who underwent septal myectomy and had at least one CMR image before surgery.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- (1) Combined right ventricular outflow tract obstruction requiring right ventricular outflow tract dissection. (2) Combined mitral or aortic valve organic lesions requiring valve replacement surgery. (3) Apical ventricular aneurysm formation requiring ventriculotomy. (4) Previous septal reduction therapy, including alcohol ablation or septal myectomy. (5) patients did not undergo cardiac magnetic resonance examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients had a higher left ventricular mass index or not （the exact value is determined by the cut-off value for the clinical outcomes)Patients were grouped by the cutoff value of left ventricular mass index (LVMI) for all cause death, and the Maximally Selected Rank Statistics method was used to determine the optimal cutoff point of LVMI for death. | Other | Obstructive hypertrophic cardiomyopathy who underwent septal myectomy |
Primary outcome
All-cause death
Time frame: One month after discharge
Any death observed one month after discharge.
1 secondary outcome
composite endpoint
Time frame: One month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)
RecruitingObservational study
A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
Hypertrophic Cardiomyopathy
Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Symptomatic Hypertrophic Cardiomyopathy (HCM)
RecruitingPhase 3
BHB-1893 Versus Metoprolol for Symptomatic Obstructive Hypertrophic Cardiomyopathy
Cardiomyopathy, Hypertrophic Obstructive
Active, not recruitingObservational study
A Study to Assess the Treatment of Obstructive Hypertrophic Cardiomyopathy (oHCM) With Mavacamten in the US
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Active, not recruitingObservational study
COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Hypertrophic Cardiomyopathy (HCM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Hypertrophic Cardiomyopathy (oHCM), run by Changrong Nie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: One month after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.